Under the Indian Medical Devices Rules (MDR) regulated by the **Central Drugs Standard Control Organization (CDSCO)**, all foreign medical device manufacturers must obtain an import license before selling their products in India.
To register successfully, foreign manufacturers require a registered local entity to serve as their **Indian Authorized Agent (IAA)**. The IAA acts as the primary liaison with the licensing authority, holds the legal registration certificates, and ensures post-market surveillance compliance.
Innoways Healthcare provides comprehensive, end-to-end regulatory consulting and IAA services, helping overseas medical technology brands enter the expanding Indian market quickly and in full legal compliance.
As your legal representative in India, we:
We simplify complex regulatory submissions into a structured four-stage process, maximizing approval rates and reducing time-to-market.
Determining device risk category (Class A, B, C, or D) to identify required clinical trial data, audits, and government fees.
Compiling the Technical Dossier, including ISO 13485 (MDQMS) certificates, Device Master Files (DMF), and Free Sale Certificates (FSC).
Uploading the application via the CDSCO online SUGAM portal, managing direct queries, and resolving technical objections from reviewers.
Securing the official CDSCO Import License (Form MD-15), allowing the manufacturer to legally import and distribute devices across India.
Regulatory compliance is crucial in the medical device field. A single error in dossier filing can delay product launch by months or result in outright rejection. Innoways Healthcare offers distinct advantages:
